Clinical Trials

Irbesartan has been evaluated across numerous clinical trials spanning Phase 1 through Phase 4, investigating primary indications such as hypertension, type 2 diabetes mellitus, chronic kidney disease, myocardial ischemia, and cardiovascular risks, as well as exploratory studies in COVID-19 and hyperkalemia. Sponsored by leading pharmaceutical corporations like Sanofi and Astellas Pharma alongside academic institutions such as Karolinska Institutet and the University of British Columbia, these studies encompass active, completed, terminated, and planned recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07555054 NOT_YET_RECRUITING
Chronic Kidney Disease
Jiangsu Hansoh Pharmaceutical Co., Ltd.
 2026-05-21 PHASE2
NCT06660940 NOT_YET_RECRUITING
Diabetic Kidney Disease; Diabetic Retinopathy
Chinese PLA General Hospital
 2024-10 PHASE4
NCT06635772 NOT_YET_RECRUITING
Immunoglobulin a Nephropathy
Hansoh BioMedical R&D Company
 2024-11 PHASE2
NCT03476616 COMPLETED
Hypertension; Obesity
Hippocration General Hospital
 2018-09-01 PHASE4
NCT05272878 ACTIVE_NOT_RECRUITING
Acute Kidney Injury
Assistance Publique - Hôpitaux de Paris
 2022-11-22 PHASE3
NCT06208072 UNKNOWN
Primary Hypertension; Obesity
Hippocration General Hospital
 2023-09-01
NCT06256991 Not yet recruiting
Chronic Kidney Diseases|Hyperkalemia|Hypertension
University Medical Center Groningen|Amsterdam University Medical Center|Medical Centre Leeuwarden|Isala|Vifor Pharma Inc.|Dutch Kidney Foundation|Health Holland
 2024-04 Phase 4
NCT05056727 TERMINATED
Renal Insufficiency, Chronic; Hyperkalemia
AstraZeneca
 2021-09-30 PHASE3
NCT06208072 Recruiting
Primary Hypertension|Obesity
Hippocration General Hospital|National and Kapodistrian University of Athens
 2023-09-01 Not Applicable
NCT03762850 ACTIVE_NOT_RECRUITING
Immunoglobulin A Nephropathy
Travere Therapeutics, Inc.
 2018-12-11 PHASE3
NCT05476354 COMPLETED
Essential Hypertension
Handok Inc.
 2022-07-05 PHASE3
NCT05475665 COMPLETED
Essential Hypertension
Handok Inc.
 2022-07-14 PHASE3
NCT03493685 COMPLETED
Focal Segmental Glomerulosclerosis
Travere Therapeutics, Inc.
 2018-04-17 PHASE3
NCT05243199 COMPLETED
CKD5 Stage Dialysis; Heart Failure
Ruijin Hospital
 2020-08-01 PHASE4
NCT05688085 COMPLETED
Healthy Volunteers
Handok Inc.
 2022-10-18 PHASE1
NCT05663073 COMPLETED
Healthy Volunteers
Handok Inc.
 2022-09-13 PHASE1
NCT05688098 COMPLETED
Healthy Volunteers
Handok Inc.
 2022-09-23 PHASE1
NCT04983979 Terminated
CKD|Diabetes Mellitus Type 2|Hyperkalemia
Barts & The London NHS Trust
 2022-06-17 Phase 2
NCT04606563 TERMINATED
Covid19; SARS-CoV Infection
University of British Columbia
 2020-10-09 PHASE3
NCT03934307 COMPLETED
Hypertension
Alnylam Pharmaceuticals
 2019-05-01 PHASE1
NCT05297929 UNKNOWN
Irbesartan Tablets (0.15g/Tablet); Under Fasted Condition; Under Fed Condition; Bioequivalence
The Affiliated Hospital of Qingdao University
 2022-02-17 PHASE1
NCT04488978 COMPLETED
Essential Hypertension
Handok Inc.
 2020-05-21 PHASE2
NCT03627715 COMPLETED
Diabetic Kidney Disease
Dimerix Bioscience Pty Ltd
 2018-11-06 PHASE2
NCT03649152 COMPLETED
Focal Segmental Glomerulosclerosis
Dimerix Bioscience Pty Ltd
 2018-11-08 PHASE2
NCT02597361 COMPLETED
Ehlers-Danlos Syndrome, Vascular Type
Assistance Publique - Hôpitaux de Paris
 2016-01 PHASE3
NCT02386293 UNKNOWN
Hypertension; Obesity; Stress, Psychological; Blood Pressure
Augusta University
 2014-04 PHASE2
NCT00657059 COMPLETED
IgA Nephropathy
Sun Yat-sen University
 2007-09 PHASE3
NCT05786339 COMPLETED
Therapeutic Equivalency
The Affiliated Hospital of Qingdao University
 2018-11-17 PHASE1
NCT03147677 COMPLETED
Type 2 Diabetic Nephropathy
The Third Xiangya Hospital of Central South University
 2016-07-28 PHASE4
NCT03016832 UNKNOWN
Diabetic Kidney Disease
Jiangsu Famous Medical Technology Co., Ltd.
 2017-01 EARLY_PHASE1
NCT02842359 COMPLETED
Type 2 Diabetes Mellitus
Sanofi
 2016-08-23 PHASE4
NCT02644486 TERMINATED
Obesity and Glomerulopathy
Zhi-Hong Liu, M.D.
 2016-01
NCT01519297 SUSPENDED
Preeclampsia; Pregnancy Induced Hypertension
Brigham and Women's Hospital
 2012-05
NCT01992796 UNKNOWN
Severe Sepsis
University of Salerno
 2014-01 PHASE3
NCT01613118 COMPLETED
Focal Segmental Glomerulosclerosis
Travere Therapeutics, Inc.
 2014-03 PHASE2
NCT02380625 UNKNOWN
Ebola Virus Disease
Clinical Research Management, Inc.
 2015-04 PHASE1; PHASE2
NCT01949233 UNKNOWN
Marfan Syndrome
University of Oxford
 2013-10 PHASE2
NCT01968759 COMPLETED
Chronic Kidney Disease
Mario Negri Institute for Pharmacological Research
 2013-10 PHASE2
NCT00933231 COMPLETED
Kidney Transplantation
Astellas Pharma Inc
 2009-08-17 PHASE3
NCT01360710 UNKNOWN
Abdominal Obesity; Hypertension
Baker Heart and Diabetes Institute
 2012-01 PHASE4
NCT01825850 COMPLETED
Healthy
LG Life Sciences
 2013-06 PHASE1
NCT01442987 COMPLETED
Hypertension; Hyperlipidemia
Hanmi Pharmaceutical Company Limited
 2011-05 PHASE3
NCT01858610 COMPLETED
Healthy
Damanhour University
 2013-03
NCT00265642 COMPLETED
Hepatitis C, Chronic
ANRS, Emerging Infectious Diseases
 2006-10 PHASE3
NCT00791830 COMPLETED
Kidney Failure, Chronic
University of Aarhus
 2009-04 PHASE3
NCT00987662 WITHDRAWN
Obesity; Hypertension
Aristotle University Of Thessaloniki
 2012-01 PHASE4
NCT01625494 COMPLETED
Hypertension
Sanofi
 2012-05 PHASE3
NCT00535925 COMPLETED
Diabetic Nephropathy
University of Campania Luigi Vanvitelli
 2005-10 PHASE4
NCT01447797 COMPLETED
Healthy
Hanmi Pharmaceutical Company Limited
 2011-09 PHASE1
NCT00125645 COMPLETED
Myocardial Infarction
University of Southern Denmark
 2005-03-01 PHASE4
NCT01238705 UNKNOWN
Hypertension; Sexual Dysfunction
LanZhou University
 2008-04 PHASE4
NCT00957554 COMPLETED
Hypertension
Sanofi
 2009-07 PHASE3
NCT00956644 COMPLETED
Hypertension
Sanofi
 2009-07 PHASE3
NCT00613496 UNKNOWN
Persistent Atrial Fibrillation
University of Magdeburg
 2009-05 PHASE4
NCT00794963 TERMINATED
Metabolic Syndrome
Northwell Health
 2008-11
NCT00950066 COMPLETED
Hypertension
Sanofi
 2009-07 PHASE2
NCT00500604 COMPLETED
Hypertension
Sanofi
 2007-07 PHASE4
NCT00152698 WITHDRAWN
Hypercholesterolemia
University of Erlangen-Nürnberg Medical School
 2009-11 PHASE3
NCT00660309 COMPLETED
Type 2 Diabetes Mellitus
Novartis
 2008-04 PHASE4
NCT00224549 COMPLETED
Hypertension
Assistance Publique - Hôpitaux de Paris
 2005-04 PHASE4
NCT00249795 COMPLETED
Atrial Fibrillation; Cardiovascular Disease
Sanofi
 2003-06 PHASE3
NCT00742066 UNKNOWN
Hypertension; Insulin Resistance; Microcirculation
Maastricht University Medical Center
 2008-03
NCT00708344 COMPLETED
Hypertension
Sanofi
 2008-06 PHASE4
NCT00670566 COMPLETED
Hypertension
Sanofi
 2008-04 PHASE4
NCT00249873 COMPLETED
Atrial Fibrillation; Vascular Risk
Sanofi
 2003-06 PHASE3
NCT00635232 COMPLETED
Hypertension
Ligand Pharmaceuticals
 2008-03 PHASE2
NCT01109212 COMPLETED
Diabetic Nephropathy
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2007-03 PHASE2
NCT00443612 COMPLETED
Hypertension
Sanofi
 2006-09 PHASE4
NCT00362258 COMPLETED
Hypertension
Sanofi
 2006-02 PHASE4
NCT00095238 COMPLETED
Congestive Heart Failure
Bristol-Myers Squibb
 2002-06 PHASE3
NCT00334581 COMPLETED
Hypertension
Sanofi
 2006-05 PHASE4
NCT00362037 COMPLETED
Hypertension
Sanofi
 2006-03 PHASE4
NCT01712139 COMPLETED
Hypertension
Roxane Laboratories
 2007-09
NCT01712126 COMPLETED
Hypertension
Roxane Laboratories
 2007-09
NCT01712113 COMPLETED
Hypertension
Roxane Laboratories
 2007-08
NCT01712100 COMPLETED
Hypertension
Roxane Laboratories
 2007-08
NCT00352560 COMPLETED
Atrial Fibrillation
Bristol-Myers Squibb
 2006-07 PHASE3
NCT00296218 COMPLETED
Myocardial Ischemia; Hypertension
Sanofi
 2006-02 PHASE3
NCT00265967 COMPLETED
Hypertension
Sanofi
 2005-09 PHASE4
NCT00110422 COMPLETED
Metabolic Syndrome; Hypertension
Bristol-Myers Squibb
 2005-11 PHASE4
NCT00343551 COMPLETED
Essential Hypertension
Novartis
 2006-05 PHASE3
NCT00335673 COMPLETED
Hypertension
Sanofi
 2006-02 PHASE4
NCT00219115 COMPLETED
Hypertension
Novartis
 2005-01 PHASE3
NCT00171080 COMPLETED
Hypertension
Novartis
 2004-04 PHASE3
NCT00095290 COMPLETED
Albuminuria
Bristol-Myers Squibb
 2004-09 PHASE4
NCT00243178 TERMINATED
Atrial Fibrillation; Vascular Risk
Sanofi
 2003-07 PHASE3
NCT00095550 COMPLETED
Hypertension
Bristol-Myers Squibb
 2004-10 PHASE3
NCT00095394 COMPLETED
Hypertension
Bristol-Myers Squibb
 2004-09 PHASE3
NCT00529750 COMPLETED
Hypertension
Sanofi
 2002-07 PHASE4
NCT00847834 COMPLETED
Hypertension
Sanofi
 2003-12 PHASE4
NCT00389168 COMPLETED
Hypertension
Karolinska Institutet
 1995-04 PHASE2; PHASE3
NCT00561964 COMPLETED
Hypertension
Sanofi
 2004-01 PHASE3
NCT00263003 COMPLETED
Hypertension
Sanofi
 2005-06 PHASE3
NCT00185055 COMPLETED
Healthy
Daiichi Sankyo
 2004-11 PHASE4
NCT00283036 COMPLETED
Hypertension
Sanofi
 2005-04 PHASE4
NCT00106561 COMPLETED
Kidney Disease; Diabetic Nephropathy; Glomerulonephritis; Proteinuria
Melbourne Health
 2002-01 PHASE2; PHASE3
NCT00347087 COMPLETED
Chronic Heart Failure
Charite University, Berlin, Germany
 2004-07 PHASE4
NCT00564187 COMPLETED
Hypertension
Sanofi
 2003-02 PHASE4
NCT00549133 COMPLETED
Hypertension; Diabetes Mellitus Type 2
Sanofi
 2003-10 PHASE4
NCT00562809 COMPLETED
Hypertension
Sanofi
 2003-07 PHASE4
NCT00320879 COMPLETED
Type 2 Diabetes; Microalbuminuria
Steno Diabetes Center Copenhagen
 2003-09 PHASE4
NCT00005010 COMPLETED
End-Stage Renal Disease; Chronic Allograft Nephropathy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00464880 COMPLETED
Diabetes Type 2
Novartis
 2005-09 PHASE1; PHASE2
NCT00317915 COMPLETED
Type 2 Diabetes; Microalbuminuria; Hypertension
Steno Diabetes Center Copenhagen
 PHASE3
NCT00225667 UNKNOWN
Atrial Fibrillation; Hypertension
Connolly, Stuart, M.D.
 2005-12 PHASE3
NCT00350038 COMPLETED
Hypertension; Dyslipidemia
Sanofi
 2005-02 PHASE4
NCT00517322 UNKNOWN
Left Atrial Volume; Hypertensive Heart Disease; Antihypertensive Drugs; Diastolic Function; Renin Angiotensin System
Università degli Studi dell'Insubria
 2007-08 PHASE4
NCT00154024 COMPLETED
Healthy Subjects
Technische Universität Dresden
 2003-03
NCT00180024 COMPLETED
Healthy Subjects
Technische Universität Dresden
 2002-01
NCT00264212 COMPLETED
Hypertension
Sanofi
 2004-08 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-04-28)

Check the Irbesartan product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Irbesartan acts as a potent and selective angiotensin II type 1 (AT1) receptor antagonist, preventing angiotensin II binding to block downstream signaling cascades that induce vascular smooth muscle contraction and aldosterone secretion. By promoting vascular relaxation and reducing systemic vascular resistance, this inhibition mediates blood pressure reduction and confers protective cardiovascular and renal effects in clinical conditions such as hypertension, chronic kidney disease, and type 2 diabetes.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.